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Cefepime

These highlights do not include all the information needed to use CEFEPIME FOR INJECTION safely and effectively. See full prescribing information for CEFEPIME FOR INJECTION. CEFEPIME (cefepime hydrochloride) for injection, for intravenous or intramuscular use Initial U.S. Approval: 1996

Approved
Approval ID

dd641c7f-b857-48ff-bd9d-747e0c3cc89f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 10, 2023

Manufacturers
FDA

Apotex Corp.

DUNS: 845263701

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Cefepime

PRODUCT DETAILS

NDC Product Code60505-6146
Application NumberANDA203704
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateNovember 22, 2021
Generic NameCefepime

INGREDIENTS (2)

CEFEPIME HYDROCHLORIDEActive
Quantity: 1 g in 1 1
Code: I8X1O0607P
Classification: ACTIM
ARGININEInactive
Code: 94ZLA3W45F
Classification: IACT

Cefepime

PRODUCT DETAILS

NDC Product Code60505-6147
Application NumberANDA203704
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateNovember 22, 2021
Generic NameCefepime

INGREDIENTS (2)

CEFEPIME HYDROCHLORIDEActive
Quantity: 2 g in 1 1
Code: I8X1O0607P
Classification: ACTIM
ARGININEInactive
Code: 94ZLA3W45F
Classification: IACT

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Cefepime - FDA Drug Approval Details